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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02065 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| IRB00106849 | |||
| RAD4500-18 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| P30CA138292 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well spectroscopic magnetic resonance imaging (MRI) guided proton therapy works in assessing metabolic change in pediatric patients with brain tumors. The non-invasive imaging, such as spectroscopic MRI may help to map the differences in tumor metabolism compared to healthy tissue without injection of any contrast agent.
PRIMARY OBJECTIVES:
I. To obtain spectroscopic (s)MRI data from pediatric high grade glioma (HGG) patients before receiving standard of care radiation therapy (RT) and correlate baseline Cho/NAA ratios to recurrence patterns. (Cohort 1, observational) II. To assess the feasibility and safety of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery. (Cohort 2, intervention)
SECONDARY OBJECTIVES:
I. To evaluate how Cho/NAA defined radiation target volumes compare to standard of care radiation target volumes in size and resulting radiation delivery to adjacent normal tissue, by creating mock comparison RT plans for each patient.
II. To compare voxel-to-voxel changes in pre-treatment and post-treatment sMRI and evaluate as potential early predictor of tumor response/recurrence.
III. To evaluate sMRI as a tool in identifying pseudoprogression vs. true progression and correlate post-treatment sMRI metabolite ratios with histopathology if collected.
IV. To report patterns of failure in relationship to the RT field (local, marginal, or distant), progression-free survival (PFS) and overall survival (OS) among all patients.
V. To report patient reported outcomes of health related quality of life (QOL) during and after proton therapy for pediatric HGG.
VI. To build a longitudinal tracking database including clinical data, imaging, and genomic molecular profiling for pediatric HGG treatment.
OUTLINE:
Patients undergo sMRI prior to radiation therapy, at 1, 4, and 7 months after RT, and at the time of suspected recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (sMRI) | Experimental | Patients undergo sMRI over less than 1 hour within 7 days prior to start of standard of care radiation therapy and at 10 weeks. |
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| Group 2 | Active Comparator | Patients will undergo 3-4 sMRI scans at baseline prior to RT, 1 month, 4 months, and 7 months after RT, and/or at any time of suspected tumor recurrence. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Spectroscopic Imaging | Procedure | Undergo sMRI |
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| Measure | Description | Time Frame |
|---|---|---|
| Cho/NAA ratios at baseline in tumor and in regions of tumor recurrence in patients receiving standard of care radiotherapy | The spatial relationship between baseline sMRI abnormalities and tumor recurrence will be reported and proportion of overlap will be quantified. | Through study completion, an average of 1 year |
| Incidence of adverse events | Toxicity will be defined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | Through study completion, an average of 1 year |
| Feasibility of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery | Will be estimated by the Kaplan-Meier Method. | From Baseline up to 3 years from treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bree Eaton, MD | Contact | 404-778-3473 | brupper@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bree R Eaton, MD | Emory University Hospital/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Proton Therapy Center | Recruiting | Atlanta | Georgia | 30308 | United States |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D063193 | Heavy Ion Radiotherapy |
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| Proton Therapy | Device | Target volume treatment |
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| Children's Healthcare of Atlanta - Scottish Rite | Not yet recruiting | Atlanta | Georgia | 30322 | United States |
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| Emory University Hospital/Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
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| D011878 | Radiotherapy |
| D013812 | Therapeutics |